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Medical device reprocessing makes stringent demands on product quality and safety and therefore calls for consistent quality, safety and hygiene management.
Often, there is a need for external persons to work in the Reprocessing Unit for Medical Devices (RUMED); such tasks include technical activities, training, inspections, audits and reference visits.
These “external persons” are e.g. employees from other departments or also persons who within the meaning of employment legislation and occupational health and safety are not employees, such as visitors, trainees, servicing tech-nicians, cleaning personnel, validation engineers or auditors, and whose health could be endangered through exposure to biological agents or who themselves could present a risk (e.g. by introduction of microorganisms or contamination).
With this recommendation the Quality Task Group aims to create awareness of the role of “external persons” with regard to occupational health and safety and hygiene.
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